Back to resultsStudy to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
Primary Purpose
Rosacea
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CLS001 (Omiganan)
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea
Eligibility Criteria
Inclusion Criteria:
- Healthy, male and non-pregnant female subjects, 18 years of age or older.
- A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.
- Subjects with the presence of telangiectasia at Baseline.
- Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema scale at Baseline.
- Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.
Exclusion Criteria:
- Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
- Subjects with nodular rosacea.
- Standard exclusion criteria.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Vehicle Gel
Arm Description
CLS001 (Omignan) gel applied once daily
Vehicle gel applied once daily
Outcomes
Primary Outcome Measures
Efficacy Absolute Change in Inflammatory Lesion Count
Absolute change in inflammatory lesion count from baseline to Week 12.
Efficacy IGA: 2 Grade Reduction
Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Secondary Outcome Measures
Efficacy The Absolute Change in Inflammatory Lesions
The absolute change in inflammatory lesions from baseline to Week 9.
Efficacy The Absolute Change in Inflammatory Lesions
The absolute change in inflammatory lesions from baseline to Week 6.
Efficacy IGA: 2 Point Reduction
Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Efficacy IGA: 2 Point Reduction
Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02576860
Brief Title
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
Official Title
A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With a 4 Week Follow-up Period
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
February 27, 2017 (Actual)
Study Completion Date
September 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maruho Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
263 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
CLS001 (Omignan) gel applied once daily
Arm Title
Vehicle Gel
Arm Type
Placebo Comparator
Arm Description
Vehicle gel applied once daily
Intervention Type
Drug
Intervention Name(s)
CLS001 (Omiganan)
Intervention Description
Topical gel
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle gel
Primary Outcome Measure Information:
Title
Efficacy Absolute Change in Inflammatory Lesion Count
Description
Absolute change in inflammatory lesion count from baseline to Week 12.
Time Frame
12 weeks
Title
Efficacy IGA: 2 Grade Reduction
Description
Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Efficacy The Absolute Change in Inflammatory Lesions
Description
The absolute change in inflammatory lesions from baseline to Week 9.
Time Frame
9 weeks
Title
Efficacy The Absolute Change in Inflammatory Lesions
Description
The absolute change in inflammatory lesions from baseline to Week 6.
Time Frame
6 weeks
Title
Efficacy IGA: 2 Point Reduction
Description
Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Time Frame
9 Weeks
Title
Efficacy IGA: 2 Point Reduction
Description
Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Time Frame
6 Weeks
Other Pre-specified Outcome Measures:
Title
Safety Adverse Events
Description
Subjects with 1 or more treatment-related Treatment-Emergent Adverse Events
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy, male and non-pregnant female subjects, 18 years of age or older.
A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.
Subjects with the presence of telangiectasia at Baseline.
Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema scale at Baseline.
Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.
Exclusion Criteria:
Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
Subjects with nodular rosacea.
Standard exclusion criteria.
Facility Information:
City
Fort Smith
State/Province
Arkansas
Country
United States
City
Rogers
State/Province
Arkansas
Country
United States
City
Manhattan Beach
State/Province
California
Country
United States
City
Oceanside
State/Province
California
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Boynton Beach
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Plainfield
State/Province
Indiana
Country
United States
City
Watertown
State/Province
Massachusetts
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Verona
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Stony Brook
State/Province
New York
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Fort Washington
State/Province
Pennsylvania
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Arlington
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Phillip
State/Province
Australian Capital Territory
Country
Australia
City
Kogarah
State/Province
New South Wales
Country
Australia
City
Liverpool
State/Province
New South Wales
Country
Australia
City
Box Hill
State/Province
Victoria
Country
Australia
City
Surrey
State/Province
British Columbia
Country
Canada
City
Courtice
State/Province
Ontario
Country
Canada
City
Peterborough
State/Province
Ontario
Country
Canada
City
Windsor
State/Province
Ontario
Country
Canada
City
Grenoble
Country
France
City
Nantes
Country
France
City
Quimper
Country
France
City
Berlin
Country
Germany
City
Bochum
Country
Germany
City
Bonn
Country
Germany
City
Friedrichshafen
Country
Germany
City
Hamburg
Country
Germany
City
Koeln
Country
Germany
City
Lingen
Country
Germany
City
Monchengladbach
Country
Germany
City
Osnabruck
Country
Germany
City
Schweinfurt
Country
Germany
City
Nijmegen
Country
Netherlands
City
Auckland
Country
New Zealand
City
Halmstad
Country
Sweden
City
Bradford
State/Province
England
Country
United Kingdom
City
Birmingham
Country
United Kingdom
City
London
Country
United Kingdom
12. IPD Sharing Statement
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Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
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